Intubation systems and methods based on airway pattern identification

ABSTRACT

An intubation system of the present disclosure intubates based on an airway pattern indicating a trachea opening. The airway pattern is determined from analysis of airway data detected by a trachea identifying device disposed on a moveable guide stylet of the intubation system. A navigation element is generated based on the airway pattern. In one embodiment, the airway pattern is a gas exchange pattern indicating a trachea opening. In another embodiment, the trachea opening transition pattern is a topographic pattern indicating a trachea opening. The guide stylet is capable of moving in a plurality of degrees of freedom in the airway following the guidance from the navigation element.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/538,686 entitled “INTUBATION SYSTEMS AND METHODS BASED ONAIRWAY PATTERN IDENTIFICATION,” filed on Nov. 11, 2014. U.S. patentapplication Ser. No. 14/538,686 is a continuation of U.S. patentapplication Ser. No. 12/764,804 entitled “INTUBATION SYSTEMS AND METHODSBASED ON AIRWAY PATTERN IDENTIFICATION,” filed on Apr. 21, 2010. Theentire contents of the above-referenced applications are herebyincorporated by reference for all purposes.

TECHNICAL FIELD

The present disclosure relates generally to systems and methods tointubate a patient, and more particularly to systems and methods tointubate a patient based on dynamic airway-specific patterns indicatinga trachea opening.

BACKGROUND

Some medical procedures are invasive and potentially dangerous althoughthey are necessary life-saving procedures. Intubation, specificallytracheal intubation, is typically performed at various medicalconditions, such as application of general anesthesia, comatose, etc.Tracheal intubation involves the placement or the insertion of anendotracheal tube (ETT) into a patient's trachea via the vocal cords toprotect the patient's airway and provide a mechanism to enableventilation. Delay and/or misplacement of the ETT, such as misplacementof the ETT into the esophagus, may cause permanent neurological damageor death. Malposition of the ETT also may jeopardize airway protectionor cause inadequate ventilation. It is therefore imperative to intubatea patient quickly and position the ETT correctly when a medicalcondition arises.

Various technologies have been developed to assist the placement of theETT into the trachea. In a laryngoscope technique, a laryngoscope isused to obtain a direct view of the glottis and the ETT is then insertedinto the trachea under direct vision or indirect vision. A laryngoscopetypically includes a blade that has various shapes and lengths and ismade of rigid materials. In a direct laryngoscope, a light source iscoupled to the guide blade to assist the view of the glottis. In a videolaryngoscope, a video camera along with a light source is positioned onthe guide blade to provide a video image to guide the insertion of theETT. When intubating a patient with the laryngoscope technique, a usertypically inserts the guide blade into a patient's mouth with one hand,and inserts the ETT into the trachea with another hand once the tracheais identified. Successful intubation is defined as a successful ETTinsertion into the patient's trachea.

Intubation may not be successful due to various reasons. Failedintubation with a direct laryngoscope may occur due to poorvisualization and identification of the glottis or vocal cords, asituation called “can't see and can't intubate.” Failed intubation witha video laryngoscope may occur due to a poor visualization or poor anglefor the ETT insertion as a result of indirect video image of the vocalcords. A situation called “can see but can't intubate” is common.Further, all current intubation is performed by two hands (i.e., onehand holding the guide blade and another hand inserting the ETT), theETT may not be inserted correctly due to poor visual-hand coordinationduring the insertion of the ETT. Furthermore, there are clinicalsituations that can make both visualization of the vocal cords andcorrect identification impossible with either direct laryngoscope orvideo laryngoscope, such as intubation for the patients with a limitedmouth opening, short or limited neck motion or neck pathologies,pregnancy and obesity, etc.

SUMMARY

The inventor herein has recognized that the above issues may beaddressed by an intubation system that identifies a trachea openingthrough airway pattern identification. In one aspect, an intubationsystem comprises a moveable guide stylet to be inserted into an upperairway of a patient to guide insertion of an endotracheal tube into apatient's trachea; at least one trachea identifying device positioned onthe guide stylet to detect airway data as the guide stylet moves in theupper airway; and an insertion guide device including a data processorconfigured to analyze the airway data to determine an airway patternindicating a position of the guide stylet relative to a trachea opening,and generate a navigation element to direct a movement of the guidestylet to the trachea opening. In one embodiment, the airway pattern isa topographical pattern. In another embodiment, the airway pattern is agas exchange pattern. In yet another embodiment, the airway pattern is asound pattern. The airway pattern indicating a position of the guidestylet relative to a trachea opening may be determined via patternmatching or pattern recognition.

The pattern matching and the pattern recognition may enableidentification of the topographic features that cannot be observed byhuman eyes or cannot be identified correctly by human eyes via a directvideo image under some clinical conditions. Further, the intubationsystem may identify one or more topographical features and select theidentifiable topographical features to determine the topographicalpattern indicating the trachea opening. Trachea identification based onanalysis of selected topographical features allows the tracheaidentification under some clinical conditions where some topographicalfeatures are not identifiable due to abnormality or trauma of theepiglottis, the vocal cords, etc. In this way, the intubation systemallows accurate and fast identification of the trachea and increases thesuccess rate of the intubation in various clinical situations.

The gas exchange pattern indicating the trachea opening makes itpossible to intubate the patient without relying on the visualization ofthe glottis or vocal cords. The pattern matching or pattern recognitionbased on a large number of data increases the accuracy of the tracheaidentification. Further, computerized data analysis can shorten the timefor the trachea identification as compared to the trachea identificationbased on the human judgment.

The intubation system of the present disclosure identifies a tracheaopening such that the guide stylet can be directed to an entrance to thetrachea. In this way, the trachea location can be identified anddifferentiated from the esophagus opening to ensure correct insertion ofthe guide stylet into the trachea.

According to yet another aspect, the intubation system comprise a bladeincluding a distal end, the distal end adjacent to a trachea openingwhen the blade is inserted into an upper airway of a patient; a guidestylet disposed in the blade and moveable along the blade to guideinsertion of an endotracheal tube into a patient's trachea; at least onetrachea identifying device positioned on the guide stylet to detectairway data as the guide stylet moves in the upper airway; and aninsertion guide device including a data processor configured to analyzethe airway data to determine an airway pattern indicating a position ofthe guide stylet relative the trachea opening, and generate a navigationelement to direct a movement of the guide stylet to the trachea opening,a display device to display the navigation element, a drive mechanism tomove the guide stylet at three degrees of freedom, and an actuatorconfigured to actuate the drive mechanism via a user of the intubationsystem.

As the guide stylet performs movement in at multiple degrees of freedom,the guide stylet's movement can be adjusted easily in response to thenavigation guidance to enable a quick search for the trachea. The bladeconfiguration can assist the guide stylet's movement in multiple degreesof freedom. Further, because the intubation system is configured toenable the ETT to move along the guide stylet, the ETT follows exactlythe same path of the guide stylet to the trachea or the ETT is in-linewith the guide stylet. Thus, the intubation system can solve theproblems of uncommon angulation for the ETT insertion. Further, theerrors associated with coordinating the ETT insertion with two hands canbe reduced or eliminated.

The in-line alignment of the ETT and the guide stylet according to thepresent disclosure can be performed manually, or via a motor drivemechanism semi-automatically or automatically. In this way, theintubation can be done easily. It should be understood that the summaryabove is provided to introduce in simplified form a selection ofconcepts that are further described in the detailed description. It isnot meant to identify key or essential features of the claimed subjectmatter, the scope of which is defined uniquely by the claims that followthe detailed description. Furthermore, the claimed subject matter is notlimited to implementations that solve any disadvantages noted above orin any part of this disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic view of an intubation device as used tointubate a patient.

FIG. 2 shows a view of a trachea opening, an esophagus opening, andtheir surroundings.

FIG. 3 illustrates an example embodiment of an intubation systemaccording to the present disclosure.

FIG. 4 is an exploded front or cross-sectional view of an example guidestylet of an intubation system according to one embodiment of thepresent disclosure.

FIGS. 5A and 5B show thermal images, schematically illustrating atopographical pattern indicating the trachea opening, an esophagusopening, and their surroundings.

FIGS. 6A and 6B illustrate gas exchange patterns during a respiratorycycle, illustrating an example gas exchange pattern indicating atrachea.

FIG. 7 shows an example navigation guidance of an intubation accordingto the present disclosure.

FIG. 8 shows an example embodiment of blade and guide stylet of anintubation system according to the present disclosure.

FIG. 9 shows another example embodiment of guide stylet of theintubation system according to the present disclosure.

FIGS. 10A and 10B show a cross section view of an intubation systemaccording to another embodiment of the present disclosure.

FIG. 11 shows an example drive mechanism for one degree of freedom ofmovement of an intubation system according to another embodiment of thepresent disclosure.

FIGS. 12A, 12B, and 12C illustrate example embodiments of a seal used inan endotracheal tube compartment of an intubation system according toanother embodiment of the present disclosure.

FIG. 13 is a schematic diagram of an intubation system according to thepresent disclosure.

FIG. 14 is a flowchart illustrating an example method to intubate apatient using an intubation system according to one embodiment of thepresent disclosure

FIG. 15 is an elevation view of an example intubation device accordingto another embodiment of the present disclosure.

FIG. 16 is a perspective view of an example intubation device accordingto another embodiment of the present disclosure.

FIG. 17 shows a cross-sectional view of a blade assembly according toanother embodiment of the present disclosure.

DETAILED DESCRIPTION

As described in more detail below, in some embodiments, an intubationsystem of the present disclosure intubates a patient based on anairway-specific pattern from airway data generated from an airway sensordisposed on a guide stylet. The airway of a human being comprises systemof conduits, i.e., conducting airway. The airway comprises an upperairway system or an upper airway and a lower airway system or a lowerairway. The upper airway and the lower airway are divided by a tracheaopening. The trachea opening is an opening defined by the vocal cords ora glottis opening. Intubation is a process to navigate an ETT from theupper airway through the trachea opening (e.g., the vocal cords, theglottis opening) into the lower airway.

When the guide stylet is inserted into an upper airway of a patient, theairway sensor detects the airway data related to the characteristics ofthe airway, such as a trachea opening. In one example, the airway dataare topographical data associated with the anatomical features of thetrachea opening. In another example, the airway data are gas exchangedata associated with the gas exchange in the airway. In yet anotherexample, the airway data are sound level associated with sound generatedby the vocal cords in the airway. The airway data are analyzed todetermine an airway pattern indicating a position of the guide styletrelative to a trachea opening. A navigation element is generated basedon the airway pattern. For example, when the airway pattern indicatesthat guide stylet is positioned away from the trachea opening or at alocation in front of the esophagus opening or adjacent esophagusopening, the navigation element is generated to indicate whether theguide stylet is at the trachea opening. In one example, the navigationelement may be a display, such as “the guide stylet is not at thetrachea opening” or “trachea is not found.” In another example, as thetrachea opening is located in front of the esophagus opening in aninsertion direction and is above the esophagus opening relative to theinsertion direction, the navigation element may be generated to provideinstructions for the guide stylet's movement according to the spatiallocation of the trachea opening and the esophagus opening. For example,the navigation element may indicate a relative position of the tracheaopening and/or provide a direction for the guide stylet's movement asthe guide stylet moves in the upper airway, such as “trachea is upward,move upward and forward” based on the airway pattern. Likewise, when theairway pattern indicates that guide stylet is positioned adjacent to thetrachea opening and in front of the trachea opening, the navigationelement may be a display, such as “the guide stylet is at the tracheaopening” or “trachea is found.”

As described in detail below, in one embodiment, the airway sensor is animage capture device and the airway pattern is a topographical patternindicating a position of the guide stylet relative to a trachea opening.In another embodiment, the airway sensor is a gas exchange detector andthe airway pattern is a gas exchange pattern indicating a position ofthe guide stylet relative to a trachea opening. In yet anotherembodiment, the airway sensor is a sound detector and the airway patternis a sound pattern indicating a position of the guide stylet relative toa trachea opening. In some embodiments, the airway pattern indicating atrachea may be identified via pattern matching techniques or patternrecognition techniques.

In some embodiments, the airway pattern may an airway pattern in frontof the trachea opening and adjacent to the trachea opening. In oneexample, the airway pattern is a topographic pattern in front andadjacent to the trachea opening, where the topographic pattern presentsthe topographical features of the trachea opening, such as distinctivefeatures of the vocal cords and other features surrounding the vocalcords. In another example, the airway pattern is a gas exchange patternin front and adjacent to the trachea opening or the gas exchange patternin the trachea, where the gas exchange pattern presents gas exchangefeatures adjacent the trachea opening or the gas exchange features inthe trachea. In still another example, the airway pattern is a soundpattern at the trachea opening (i.e., the vocal cords) or the soundpattern in the trachea, wherein the sound pattern is recognizable.

FIG. 1 shows a schematic view of an intubation device 10 as used tointubate a patient. Intubation device 10 includes a blade 12 and alaryngoscope 14 configured to provide a view of an epiglottis and vocalcords. Blade 12 is adapted to be inserted into a patient's trachea 24via an upper airway of a patient, i.e., via a patient's mouth 20 andvocal cords 22. FIG. 1 also illustrates possible paths during the bladeplacement. As shown in FIG. 1, epiglottis 28 and glottis 30 are in thefront of vocal cords 22. Esophagus 32 is under trachea 24. Trachea 24 islocated anterior to esophagus 32. Two cavities, trachea 24 and esophagus32, are adjacent each other. Thus, blade 12 may be inserted into eithertrachea 24 or esophagus 32. Positioning of the ETT into the esophagusresults in failure of the intubation and may jeopardize airwayprotection or cause inadequate ventilation.

FIG. 1 shows that blade 12 is inserted into the mouth and a blade tip ispositioned in front of the trachea opening along a line A. When it isdetermined that blade 12 is at the opening of trachea 24, the ETT (notshown) is pushed into trachea 24. Once the ETT is in the trachea, blade12 is removed from trachea 24 and the intubation is completed. The ETTtube remains in trachea 24 for a period as required for the medicalprocedure.

FIG. 2 shows a view of a trachea opening, an esophagus opening and theirsurroundings. Trachea is an open tube-like cartilage structure withvocal cords as its opening while esophagus 32 is a muscle and connectivetissue structure collapsed in the absence of swallowing. The shape ofthe trachea opening or the vocal cords is substantially different fromthe shape of the esophagus opening in the size, and the anatomicalrelationship to epiglottis 28, glottis 30 and arytenoids cartilages 34.As such, the structural features constitute topographical features thatdistinguish the trachea opening from the esophagus opening.

Further, vocal cords 22 at the trachea opening possess specificfeatures. As shown in FIG. 2, vocal cords 22 consist of twin infoldingsof mucous membrane stretched horizontally across the larynx and open inan inverse V-shape. Unlike its surrounding structures, vocal cords 22are white-colored, which constitutes another identifiable feature.Additionally, while the vocal cords or folds typically remain still atrest, the vocal folds vibrate during phonation and thus create anadditional identifiable feature. Furthermore, the vocal cord is anarrowest part that divides the upper airway and a lower airway, whichpossess characteristics or a specific air flow pattern thatdifferentiates the vocal cord from the other structures of the upperairway and from the esophagus opening. The variations of the dimensionof the vocal cords opening and the vocal cords' motion create additionalidentifiable features.

Further, additional topographical features include, but are not limitedto, the spatial relationship, relative position, relative color of theepiglottis, the arytenoids cartilages, the vocal cords, the tracheaopening, and the esophagus opening.

One or more of the topographic features described above form atopographical pattern. The topographical pattern indicating the tracheaopening can be identified from the image data captured by an imagecapture device. In other words, one or more of the topographic featurescan be used as biometrics for the trachea identification via anyappropriate data analysis techniques.

In addition to the topographic pattern indicating the trachea opening, agas exchange pattern of the trachea can be used for the tracheaidentification as described in detail below. Furthermore, a soundpattern can be used for the trachea identification as described indetail below.

FIG. 3 illustrates an example embodiment of an intubation system 40according to the present disclosure. Intubation system 40 typicallyincludes a guide blade or a blade 42 and an insertion guide device 44. Aguide stylet 46 is disposed in the blade 42. In some embodiments, guidestylet 46 may be configured to be positioned in a center of blade 42along a blade's length and connected with insertion guide device 44electronically and mechanically. An endotracheal tube compartment 48 maybe included in an insertion guide device enclosure 50 such that an ETT52 can be preloaded thereof. In the depicted embodiment, ETT 52 ispositioned in such way that a longitudinal axis of ETT 52 issubstantially concentric with a longitudinal axis of guide stylet 46. Inthis way, ETT 52 can be slipped over guide stylet 46 and pushed in withthe same moving path as that of guide stylet 46. Alternatively, thelongitudinal axis of ETT 52 may not be overlapped with the longitudinalaxis of guide stylet 46. ETT 52 is positioned side-by side with guidestylet 46 as ETT 52 is pushed into blade 42. The ETT's movement can beguided by guide stylet or a blade body during the ETT insertion.

Insertion guide device 44 may include a mechanism for identifying thetrachea and directing the insertion of ETT 52. The trachea may beidentified with a trachea identifying device or by analyzing datadetected by a trachea identifying device. The trachea identifying devicemay be disposed on a tip portion of the guide stylet to detect variousdata that can be used to identify the trachea as described in detailbelow. In some embodiments, insertion guide device 44 may include a dataprocessor configured to receive the data detected by a tracheaidentifying device, analyze a pattern of the detected data and generatea navigation element to direct the guide stylet's movement. Thenavigation element may be a navigation guidance display generated bysoftware or hardware of the intubation system. Alternatively, thenavigation element may be a directional movement generated by thesoftware, hardware or a controller to enable semi-automatic or automaticmovement of the guide stylet.

The navigation element indicates whether the guide style is in thetrachea opening or in the trachea as the guide stylet is moving in theairway. When the navigation element indicates that the guide stylet isin the trachea opening, ETT 52 can be moved in the airway following theguide stylet' path. Once ETT 52 is inserted into the trachea, the guidestylet is withdrawn and the intubation is completed.

Additionally, or alternatively, intubation system may include a displaydevice 54 to display the navigation element. For example, display device54 may display the navigator to direct the guide stylet's movement, suchas “trachea not found” or “trachea found” as the guide stylet moves inthe airway. The guide stylet's movement can be adjusted based on thenavigation element. Further, display device 54 may present the detectedreal time data or the airway pattern as the navigation element. In thedepicted embodiment, display device 54 is a separate component and ispositioned adjacent to blade 42. It should be appreciated that displaydevice 54 may be disposed on any positions suitable for an operation ofan intubation system. Display device 54 may be connected to insertionguide device 44 via wire connection or wireless connection. In someembodiments, display device 54 may be a display screen remotely locatedfrom insertion guide device 44. Alternatively, display device 54 may beintegrated into insertion guide device enclosure 50.

Intubation system 40 may also include a drive mechanism to drive or moveguide stylet 46. The drive mechanism may cause the guide stylet's tomove in one degree of freedom or multiple degrees of freedom such thatthe guide stylet can be moved in any desired directions for locating thetrachea. In some embodiments, an actuator 56 may be used to operate theintubation system semi-automatically by a user. For example, theactuator 56 may be a joystick that is controlled by the user to moveguide stylet 46 in any desired directions based on the navigationelement presented in display device 54.

Intubation system 40 may further include a controller to drive the guidestylet automatically. The controller may be configured to receive thedata detected by the trachea identifying device, analyze a pattern orpatterns of the detected data, generate a navigation element, and adjustthe movement of the guide stylet by the drive mechanism based on thenavigation element. In some embodiments, actuator 56 may be configuredto initiate the automatic insertion of the guide stylet and override theautomatic intubation if necessary.

Additionally, or alternatively, intubation system 40 may include alock/release device 58, such as a solenoid to couple guide stylet 46and/or ETT 52 during the intubation as described in detail below.

Further, intubation system 40 may include a power supply 60 thatprovides power required by the electronic and/or mechanical componentsof the intubation system. In some embodiments, power may be suppliedfrom an external power source, such as an AC outlet or external powersource or combination of the two power sources. Alternatively, powersupply 60 may include one or more batteries in a battery compartment ofpower supply 60.

FIG. 4 is an exploded front or cross-sectional view of an example guidestylet 46 of an intubation system according to one embodiment of thepresent disclosure. FIG. 4 illustrates the example trachea identifyingdevices disposed on a tip portion of the guide stylet. The tracheaidentifying devices are used to identify or locate a trachea or atrachea opening with any appropriate mechanisms. The trachea identifyingdevices may also be referred as the trachea opening identifying devices.The trachea identifying devices include, but not limited to a lightsource, an image capture device, a gas exchange detector, a sounddetector, and a light detector as described in detail below. It shouldbe appreciated that one trachea identifying device can be used alone inan intubation system for the trachea identification, or a combination oftwo or more trachea identifying devices can be used in an intubationsystem for the trachea identification.

Guide stylet 46 may include one or more of light sources 62. Lightsources 62 may include a light-emitting diode (LED) or fiber optics.Light sources 62 provide illumination in front of the guide stylet toenable viewing of a trachea opening and its surroundings by a user ofthe intubation system or provides illumination for an image capturedevice 64 disposed on the guide stylet. In some embodiments, lightsources 62 operate to indicate the trachea opening. For example, a usercan identify the trachea opening through a direct view of the glottis orvocal cords under the light provided by light sources 62.

In some embodiments, one or more image capture devices 64 a and 64 b orimage sensors may be disposed on guide stylet 46. The image capturedevice may be a video camera to continually capture images or a stillcamera to capture still images. In another example, the image capturedevice may be a thermal camera or an infrared camera to capture thermalimages. Thermal images are generated based on the temperature differenceof captured objects. It should be appreciated that the intubation systemmay include one or more types of cameras. Further, the intubation systemmay include two or more cameras of the same type and positioned indifferent locations of guide stylet 46. For example, two or three videocameras may generate two or three-dimensional image. The threedimensional images may identify the topographic features that cannot beidentified by a two-dimensional image.

In some embodiments, the trachea identifying devices disposed on theblade may include one or more gas exchange detectors 66 a, 66 b, 66 c,and 66 d to detect dynamic gas exchange data during a respiratory cycle.The gas exchange data may include temperature, air flow rate, positiveor negative pressure, concentrations of carbon dioxide (CO₂), oxygen, ornitrogen. In one example, the gas exchange detectors may be atemperature sensor, an airflow sensor, a pressure sensor, a CO₂ sensor,an oxygen sensor, a nitrogen sensor, or a humidity sensor. It should beappreciated that one type of gas exchange detector may be used in theintubation system or two or more of different types of gas exchangedetector may be used in the intubation system. Further, it should beappreciated that the gas exchange detector may be any suitable sensorsthat can detect the variables, such CO₂, oxygen and nitrogen, flowrateor pressure qualitatively or quantitatively with an appropriate responsetime to the concentration changes. Further, one gas exchange detectorcan be used in combination with one image capture device. In oneembodiment, a CO₂ sensor may used to confirm the trachea location afterthe trachea is identified by the image data.

It should be appreciated that the trachea identifying device may includeany device that can distinguish the trachea from the esophagus. In oneexample, the trachea identifying device may be a sound detector or asound homing device. The sound homing device may include an arrangementof a plurality of microphones in the guide stylet to record sounds fromdifferent locations to detect vocal cord location. The trachea may beidentified when sound in a predetermined decibel level is detected. Inanother example, the trachea identifying device may be a sound detectorto detect sound in the trachea generated by phonation, or specialphonation or sound, such as “Ah or Oh.” The sound features may includedecibel level of the sound. The sound pattern or sound recognition maybe determined by any techniques known in the art.

Additionally, in some embodiments, the trachea identifying devices maybe one or more detector that can sense a compound or a tracer introducedinto the patient's gas exchange by inhalation, digestion or injection.For example, the compounds may include intravenous alcohol, helium,inhalation anesthetics (e.g., desflurane, isoflurane, sevoflurane),Xenon, or nitrous oxide (N₂O), etc. Detection of the introduced compoundcan indicate the trachea location.

Additionally, in some embodiments, the trachea identifying devices maybe one or more signal sensors that can sense a signal generated by asignal generator attached to the patient. Referring back to FIG. 1, asignal generator 36 may be disposed on a patient's neck. In one example,signal generator 36 may be a light source configured to generate anysuitable light, such as visible light, ultraviolet, infrared, laser,etc. In another example, signal generator 36 may be a sound deviceconfigured to create and send sound, such as audible sound or ultrasoundin any suitable decibel level to trachea 24. Thus, the signal sensor maybe a light sensor or a sound sensor capable of detecting the introducedlight or sound. It should be appreciated that signal generator 36 may bedisposed on the patient's neck 38 above trachea 24 as shown in FIG. 1 orsignal generator 36 may be disposed inside the patient body and adjacentto trachea 24. The intubation system allows the trachea identificationbased on the introduced signal in some conditions, such as un-breathingpatient, or abnormal airway.

Returning to FIG. 4, additionally, or alternatively, direction controlcables 68 may be coupled to blade 42. As described below, in someembodiments, direction control cables 68 may be used to adjust themovement of guide stylet 46 in any desired direction by a drivemechanism for semi-automatic or automatic intubation.

Additionally, or alternatively, a precision light guide 70 may bedisposed on guide stylet 46 to direct the insertion of the ETT. In oneexample, precision light guide 70 may be a laser pointer or other lightpointers to generate a straight light ray that point toward a directionof an ETT pathway. Precision light guide 70 may be positioned adjacentto the trachea identifying device in an orientation such that the lightpath of precision light guide 70 is aligned with a moving path of thetrachea identifying device. In this way, the light ray from alignmentaid is directed to the trachea opening when the trachea is identified.As such, the ETT can follow the light ray when the ETT is pushed intothe airway.

As described above, insertion guide device 44 may include one or moremechanisms for the trachea identification. In some embodiments, a dataprocessor of insertion guide device 44 may be configured to receive thedata detected by a trachea identifying device, analyze a pattern of thedetected data and generate a navigation guidance based on the pattern.For example, the trachea identifying device may be an image capturedevice and the pattern may be a topographical pattern. Referring back toFIG. 2, an image captured by a video camera or a still camera may bedisplayed in display device 52 as shown in FIG. 2. As the camera movesin the airway, the images are captured continually or periodically andthe real time image data are analyzed for the topographical patternindicating a trachea opening.

The image data may be analyzed for the presence of the topographicalfeatures. As described above, the topographical features include theconfiguration of the vocal cords, such as an inverted “V” shape at rest,distinguished white color, vibrated folds of the vocal cords atphonation and the dynamic thermal image changes during a respiratorycycle. The topographical features further include structures surroundingthe vocal cords, such as the shape of the epiglottis and arytenoidscartilages, and the esophagus opening as well as the vocal cords'spatial relationship and the vocal cords' relative color to itssurrounding structures. In some embodiments, the topographical featuresof the vocal cords may be used alone to identify the vocal cords or thetrachea opening. In other embodiments, the topographical features of thevocal cords may be used as a major identifier, and other topographicalfeatures surrounding the vocal cords and their relationship may be usedas additional identifiers to confirm the trachea opening identification.

The topographical pattern indicating the trachea opening may beidentified using any appropriate data processing technologies thatidentify a pattern based on the specific features. In one embodiment,the image data may be analyzed using pattern matching that checks forthe presence of the constituents or features of a given pattern. Forexample, the image data may be analyzed for the presence of thetopographic features by comparing a predetermined pattern. Thepredetermined pattern may be a specific topographic pattern for adultsor a specific topographic pattern for children. Additionally, thepattern matching may include a comparison with a predetermined patternfor patients with an abnormal airway.

Pattern matching may include checking the presence of one or more of thetopographical features in the captured data. In one example, it may bedetermined that the topographical pattern indicating the trachea openingis present if the captured image data include features matching thestructural features of the vocal cords and/or epiglottis. In anotherexample, it may be determined that the topographical pattern indicatingthe trachea opening is present if the captured image data includefeatures matching the features of the vocal cord folds vibration or themotion in the trachea opening during phonation. Based on the analysis ofthe topographical pattern, the navigation guidance may be generated todirect the movement of the guide stylet. It should be appreciated thatthe navigation guidance may be generated if any single topographicalfeature matches with the predetermined pattern or if two or moretopographical features match with the predetermined pattern. Further, itshould be appreciated that any appropriate mathematic models can be usedfor pattern matching.

The pattern matching may enable identification of the topographicfeatures that cannot be observed by human eyes or cannot be identifiedcorrectly by human eyes via a direct video image under some clinicalconditions. Further, the trachea identification based on analysis ofselected topographical features allows the trachea identification undersome clinical conditions where it is difficult to identify sometopographical features due to abnormality or trauma of the epiglottis,the vocal cords, etc. Further, the pattern matching has the advantage ofselecting a predetermined pattern to be adapted to different groups ofpatients.

In some embodiments, the image data may be analyzed using patternrecognition based on the categories of the pattern. The patternrecognition technique may include collecting data, extracting features(e.g., numeric or symbolic information from the data) from the collecteddata and classing/categorizing the data based on the extracted features.Any appropriate pattern recognition technique can be used for thepattern recognition. In one example, the pattern recognition may bebased on a prior knowledge via supervised learning. That is, theclassification may be based on a set of classified or described patternscalled the training set. In another example, the pattern recognition mayestablish the classes based on statistical regularities of the pattern,i.e., unsupervised learning. The data processor of the presentdisclosure may store one or more sets of classified patterns with thetopographic features and perform the pattern recognition via thesupervised learning. Alternatively or additionally, the data processorof the present disclosure may perform the pattern recognition based on astatistical model of the topographic features via unsupervised learning.Again, the topographic features may be one or more of the topographicfeatures of the trachea, the esophagus and their surrounding, and thetrachea identification may be based on recognition of one or more of thetopographic features. The navigation guidance may be generated based onthe pattern recognition. It should be appreciated that any appropriatemathematic models or algorithms can be used for pattern recognition.

In some embodiments, the data processor may further include locking thetrachea opening once the trachea is found by a technique calledtargeting and locking. Referring back to FIG. 2, the image shown in FIG.2 may be captured by the image capture device and displayed on a displaydevice. A block 72 may appear in the image and block 72 follows thetrachea opening as the guide stylet moves in the airway. In this way,the guide stylet's movement can be adjusted following block 72 andcompensating the involuntary movement of the operator or patient.

In some embodiments, a controller or the data processor may include aposition tracking module to track a position of the guide stylet via animage corresponding to the position. In one example, the positiontracking module may include a predetermined map with a relationshipbetween the airway images and positions of the guide stylet. As such,during the intubation, a current position of the guide stylet relativeto the trachea opening (e.g., up, down, right or left relative to thetrachea opening) may be determined by comparing the captured image withthe predetermined map. Further, the position of the guide stylet and thereal time movement of the guide stylet may be displayed on the displaydevice along with the navigation element. The navigation element mayfurther provide instructions indicating the location of the tracheaopening, such as up, down, right or left relative to the currentposition of the guide stylet.

Again, as pattern recognition is conducted on a significant amount ofreal time data for the regularities or classification, patternrecognition may enable identification of the topographic features thatcannot be observed by human eyes. The features identifiable by thepattern recognition are referred to as the machine recognizablefeatures. Further, the identification of one or more machinerecognizable features as opposed to the observation on an overallvisualization of an image allows the correct trachea identificationunder the clinical conditions where an intubation is not possible by adirect view or a video image.

It should be appreciated that any suitable data processing may be usedto analyze the topographical pattern indicating the trachea opening. Forexample, the data processor may include an image reconstruction moduleor an algorithm to recreate an image based on the captured image data.For example, an undiscernible topographical feature from a capturedvideo image may be enhanced on a processed image once the feature isidentified by the image reconstruction module. Alternatively, a missingtopographical feature in the captured image may be superimposed into theprocessed image so that the trachea opening can be identified. Theprocessed image can be displayed to a user. The processed image canimprove the visualization of the trachea opening. In one example, theprocessed image alone can be displayed and used as the navigationelement.

Further, the captured images may be used to identify the trachea withoutadditional data processing. In some embodiments, the trachea identifyingdevice may be a thermal camera or an infrared camera to capture thethermal images. FIGS. 5A and 5B show thermal images, schematicallyillustrating a topographical pattern indicating the trachea opening, anesophagus opening, and their surroundings. The temperatures in thetrachea and esophagus are different. The temperature variation can becaptured by the thermal camera. The thermal image may show the differenttemperature regions in different colors. In the depicted embodiment, alighter shade represents a higher temperature while a darker shaderepresents a lower temperature as shown in a temperature bar T. In oneexample, the inverse V shape shown in the thermal image can be used toidentify the vocal cords, and thus identify the trachea. In anotherexample, temperature variations of glottis 30 or a vocal cord openingduring a respiratory cycle can be used to identify the trachea as thethermal images changes during the respiratory cycle. For example, airflowing into the airway may be at the ambient temperature (e.g., roomtemperature of 24° C.) and the air flowing out of the trachea may attemperature of up to 32° C. FIG. 5A shows an example thermal imageduring the exhalation. As the exhaled gas has higher temperature,glottis is shown to have a lighter color. FIG. 5B shows an examplethermal image during the inhalation. As the inhaled gas has lowertemperature, the vocal cord opening or glottis 30 is shown to have adarker color. The color of glottis 30 shows significant changes in therespiratory cycle. In other words, the topographical features mayinclude the thermal image color variations of the vocal cords and avocal cord opening due to temperature changes in a respiratory cycle ofthe patient.

Further, the extent of the temperature difference can be furtheramplified by lowering the temperature of the inhaled air. As such, itcan be determined the topographical pattern indicating the tracheaopening once the significant color change of glottis are observed duringthe respiratory cycle. In this way, the images captured by the thermalcamera can be use as the navigation guidance without additional dataanalysis, such as pattern matching or pattern recognition.Alternatively, additional data analysis, such as pattern matching orpattern recognition may be also used.

In some embodiments, the trachea identifying device may be an airwaysensor and the pattern may be a gas exchange pattern. The gas at thetrachea opening, the vocal cords, or the trachea demonstrate the gasexchange pattern while the gas exchange pattern is absent in theesophagus opening. FIGS. 6A and 6B illustrate gas exchange patternsduring a respiratory cycle, illustrating an example gas exchange patternindicating a trachea opening or a trachea. Human breathing consists ofinhalation and exhalation or a breathing cycle or a respiratory cycle. Arespiratory cycle is dynamic and typically occurs twelve (12) to twenty(20) times per minute. Inhalation and exhalation result in gas exchangeor air exchange between a respiratory system of a human and ambient air.The gas exchange occurs in the trachea while there is no gas exchange inthe esophagus. As such, a gas exchange pattern can be used to identifythe trachea.

A respiratory cycle can be divided into five phases. The phase 0 is aninhalation phase with an inflow of ambient air. In the phase I,exhalation begins as air in the respiratory system flows out, with deadspace ventilation. In the phase II, exhalation continues with the mixingof dead space and alveolar gas. In the phase III, air continues to flowout but alveolar gas is stabilized. In the phase IV, the outward airflowdecreases and the exhalation ends. As illustrated in FIGS. 6A and 6B,each phase can be characterized by the changes of the gas exchangevariables associated with the inhaled and exhaled air, such as airflowrate, air pressure, CO₂ and O₂, N₂, or humidity, etc.

Some gas change variables are at a lower level in the ambient air butthe level increases after exchanging with gas in the lungs. Suchvariables include CO₂, temperature and humidity. FIG. 6A illustrates anexample gas change pattern of CO₂, temperature and humidity. The Phase 0is an inhalation phase with an inflow of ambient air. When air is flowedinto the airway, CO₂ concentration is at the atmosphere level, i.e.,approximately 0.04% CO₂ in the airflow. Similarly, the temperature andhumidity are at the ambient temperature (e.g., room temperature of 24°C.) or ambient humidity. In the phase I, the air starts flowing out butthe CO₂, temperature and humidity are still at the atmosphere level. Inthe phase II, as the air starts flowing out from the trachea, the gasexchange variables, such as CO₂ concentration, temperature and, humidityvary. For example, the expired air has higher temperature than theinspired air due to heat exchange in the lungs. Further, the expired airhas higher vapor than the inspired air due to fluid exchange in thelungs. Similarly, CO₂ concentration increases after gas exchange in thelungs. FIG. 6A shows that gas exchange variables (e.g., CO₂concentration, temperature, and humidity) increase rapidly. In the phaseIII, the CO₂ concentration, temperature and humidity continue toincrease slowly. The CO₂ concentration may be reached a level of 5% CO₂,the temperature may rise to 32° C. and the humidity may be up to 5% ofwater content. In the phase IV, the CO₂ concentration, temperature andhumidity continue to increase to the highest level of the respiratorycycle.

It should be noted that the air flow or pressure may follow the similarpattern illustrated in FIG. 6A. For example, the exhaled air flowrateand air pressure increase and then decrease during the exhalation phase.

The gas change variables, such as oxygen are at a higher level in theambient air but the level decreases after exchanging with gas in thetrachea. FIG. 6B illustrates an example gas change pattern of O₂ duringthe respiratory cycle. In the phase 0, air flows into the airway and theO₂ concentration is at the atmosphere level, i.e., approximately 21% O₂in the airflow. In the phase I, the air starts flowing out but O₂concentration is still at the atmosphere level. In the phase II, O₂concentration decreases quickly and may be lowered to 14% O₂. In thephase III, O₂ concentration continues to decrease. In the phase IV, O₂concentration decreases to a lowest level of the respiratory cycle.

It should be noted that the gas change pattern is not limited to theexamples described above. Any detectible pattern during a respiratorycycle may be used to identify the trachea. Further, the characteristicsof inhaled air may be modified to make the pattern more discernable. Forexample, the temperature, humidity, oxygen concentration of the inhaledair may be adjusted to a predetermined value and delivered throughintubation system or a face mask to the patient such that desiredvariations of the temperature, humidity, oxygen concentration during therespiratory cycle can be obtained. In one example, the temperature ofthe inhaled air may be lowered and the O₂ concentration of the inhaledair may be increased to create greater temperature and the O₂concentration differential if desired.

As described above, the gas exchange data, such as CO₂ and O₂concentrations, temperature, airflow, or pressure can be detected by anappropriate gas exchange detector. The detected gas exchange data may bepresented in a graphical format as shown in FIGS. 6A and 6B to displaythe gas exchange pattern. The presence of the gas change pattern canindicate that the guide stylet is adjacent to the trachea opening or inthe trachea. Thus, the gas exchange pattern as shown in FIGS. 6A and 6Bcan be used as navigation guidance.

Additionally, the detected data can be analyzed for the gas exchangepattern indicating the trachea. The gas exchange features may include,but are not limited to, CO₂ or oxygen concentration at a predeterminedthreshold, temperature, humidity, flowrate or pressure at apredetermined level. The gas exchange features may further includeabrupt changes of the gas change data from the phase I to the phase IIor from the phase IV to the phase 0. The gas exchange features mayfurther include a continued increase or a continued decrease of detectedgas exchange data during the phase II, III or IV.

As described above with reference to the topographical pattern, anyappropriate data analysis techniques may be used to identify the gasexchange pattern indicating the trachea. For example, the patternmatching may be used by comparing the detected gas exchange data with apredetermined gas exchange pattern, threshold values, other gas exchangefeatures. In another example, the gas exchange pattern indicating thetrachea may be determined by pattern recognition based on the gasexchange features. The pattern recognition may be based on supervisedlearning or unsupervised learning as described above. The navigationguidance may be generated based on the gas exchange data analysis.

Alternatively, or additionally, a sound pattern may be used to identifythe trachea. In one example, the intubation system is patient specificand can learn a patient's voice by recording the patient's sound beforethe intubation and the sound can be stored and recognized by theintubation system using any voice recognition technology. During theintubation, the patient can be asked to generate sounds, such as “aaa,eee, woo.” A sound detector, such as a microphone or an acoustic cameracan be used to detect the sound. The intubation system can match thedetected sound with the stored sound pattern and generate the navigationguidance.

FIG. 7 shows examples of navigation element displayed as shown on adisplay device 54 of an intubation system according to one embodiment ofthe present disclosure. The navigation element 55 may include one ormore user viewable navigation guidance displays to direct the movementof a guide stylet of the intubation system. As described above,navigation element 55 is generated based on the analysis and orprocessing of the detected data related to the trachea. During theintubation, navigation element 55 may be presented dynamically indisplay device 54 as the guide stylet moves in a patient's airway. Inone example, navigation element 55 may be displayed as a statement 55 a,such as “Trachea found” when the trachea is identified based on thedetected data. Likewise, navigation element may be displayed as “Tracheanot found” when the guide stylet is not in a position of a tracheaopening or in the trachea.

In another example, navigation element 55 b may be shown as an image ofthe trachea opening, an esophagus, and their surrounding. Navigationelement 55 b may be a thermal image, a video image, or a processedimage. A user can identify the trachea via the topographical featuresdescribed above or can identify the trachea by observing the variationsin a respiratory cycle, such as the color variation of the glottis in athermal image during a respiratory cycle and the motion of the vocalcords during phonation. In yet another example, navigation element 55 cmay be a gas exchange pattern. The user can determine whether the guidestylet is in the trachea by observing the gas exchange pattern. In stillanother example, navigation element 55 d may include instructions, suchas directions on how to move the guide stylet. In another example,navigation element 55 d may be a directional movements enabled by acontrol of the intubation system. In another example, the navigationelement may include a captured image with a target, such as a block (notshown) that continues to move and target the trachea in the image. Itshould be appreciated that one or more examples of navigation elementillustrated can be presented in display device 54 simultaneouslydepending on the trachea identifying device and data analysis of theintubation system.

FIG. 8 shows an example embodiment of blade 42 and guide stylet 46according to the present disclosure. Blade 42 may have various shapesand dimensions. In the depicted embodiment, blade 42 is curved and issized to have a length L such that a distal end 43 of blade 42 isadjacent to a trachea opening when blade 42 is placed into a patient'smouth. Further, a width of the blade may be configured to receive theguide stylet and the ETT and adapted to accommodate the guide stylet'smovement along the blade and an insertion of the endotracheal tube overthe guide stylet. A shape of blade may be adapted to facilitate moving apatient's tongue forward and upward. In this way, blade 42 may be usedas a guide rail to facilitate the guide stylet's movement. Guide stylet46 can be extended from distal end 43. In the extended position, distalend 43 may be used as a fulcrum for a tip portion of guide stylet toperform the desired movements.

In some embodiments, blade 42 may include a bottom wall 80 as the guiderail for the forward and backward movement. Additionally, blade 42 mayinclude a side wall 82 extending from the bottom wall such that guidestylet 46 is moved against side wall 82 without deviating from aninsertion direction or moving away from the blade. In other embodiments,blade 42 may include a top wall 86 to define the guide stylet's up anddown movement and to avoid a bite of the guide stylet by the patient.Alternatively, blade 42 may include another side wall (not shown)opposite to side wall 82 such that guide stylet 46 is enclosed along itslength. Openings 84 may be incorporated into side wall 82 to allow theobservation of the guide stylet's movement and the ETT movement. Itshould be appreciated that blade 42 may be in straight configuration orblade 42 may have any desired length.

Guide stylet 46 may be configured to be moved in multiple degrees offreedom (DOFs). For example, guide stylet 46 may perform “up and downmovement” referred to as a first DOF, “right and left movement” referredto as a second DOF, and “forward and back movement” referred to as athird DOF. The multiple DOF movements may be caused by a drive mechanismvia activation of an actuator on the intubation system by a user.Alternatively, the multiple DOF movements may be caused by a drivemechanism automatically via a controller of the intubation system.Alternatively, a user may move the guide stylet manually to perform themultiple DOF movements.

FIG. 9 shows another example embodiment of a guide stylet 246 accordingto the present disclosure. Guide stylet 246 typically includes a tipportion 274, a joint portion 276 and a guide stylet body 278. Thetrachea identifying devices, such as an image capture device, a gasexchange detector and a light source may be disposed on or attached totip portion 274 as described above with reference to FIG. 4. The tracheaidentifying devices can generate information related the surroundings oftip portion 274. For example, the attached image capture device has aline of sight as seen from tip portion 274 and sees a view in front oftip portion 274. In another example, the gas exchange detector sensesthe conditions surrounding or adjacent to tip portion 274. When tipportion 274 is in a trachea opening or in the trachea, the attached gasexchange detector can sense the gas exchange characteristics or gasexchange patterns.

Joint portion 276 has a predetermined length and is capable of beingdeflected in any directions. Joint portion 276 may be made of flexiblematerials or made of rigid material, such as metal in a coiled form.

Stylet body 278 is shown to include a tube and a plurality of cables 280disposed inside the tube. Cables 280 may include a light bundle (e.g.,fiber optics) and/or a camera cable. In some embodiments, cables 280 mayinclude direction control cables that can be articulated by a drivemechanism to direct tip portion 274 to a desired direction. Thearticulation of the direction control cables may adjust the direction ofthe tip portion, and thus enable multiple DOFs movement of the guidestylet.

It should be appreciated that the guide stylet may have variousconfigurations. For example, the tip portion, the joint portion and theguide stylet body may be made from different materials with differentrigidities. Alternatively, the tip portion, the joint portion and theguide stylet body may be made from the same material and may be rigid orflexible along the length of the guide stylet. Further, it should beappreciated that the guide stylet may be used together with a blade inthe intubation system according to the present disclosure. As describedin the present application, the blade may facilitate the multiple DOFmovements of the guide stylet. Alternative, the guide stylet may be usedalone without the blade for the trachea identification.

FIGS. 10A and 10B show a cross section view of an intubation system 100according to another embodiment of the present disclosure, illustratinga blade, an ETT compartment and a drive mechanism. As shown in FIGS. 10Aand 10B, intubation system 100 may include a blade 142 and a guidestylet 146 disposed inside blade 142. Blade 142 may include a body 102having a distal end 108. Blade 142 is formed of a curved shape towardthe distal end or as shown or along its length. Blade 142 may include abottom wall 104 and a side wall 106. Bottom wall 104 may be configuredto have a length L such that distal end 108 of bottom wall 104 islocated adjacent to a trachea opening or an esophagus opening during anintubation. In some embodiments, blade 142 may further include a topwall 110 and a side wall (not shown). Blade 142 may be configured tohave three walls and leave one side open to facilitate an ETT balloonwire (not shown) and visual observation of the insertion of ETT 52and/or guide stylet 146. Bottom wall 104, top wall 110 may be configuredto have a shape to accommodate the insertion of the guide stylet and theETT and have less trauma to the patient.

Blade 142 may be rigid and made of metal or plastic materials ofsufficient strength. Because of the rigidity, bottom wall 104 canfunction as a guide rail to facilitate the third DOF movement (i.e.,forward and backward) of guide stylet 46. In some embodiments, distalend 108 may serve as a fulcrum or a pivot point for a first DOF movementof guide stylet 46 (e.g., up and down). Similarly, a distal end of sidewall 106 and side wall 112 may serve as a fulcrum for the second DOFmovement of guide stylet 46 (e.g., right and left).

In some embodiments, blade 142 may be releasably connected to theintubation system via any appropriate connections, such as a screw, asnap fitting, a clip fitting or a solenoid. A user of the intubationsystem can select the blade adapted for a specific patient group, suchas adults or children. The blade may be reusable.

ETT 52 may be preloaded or loaded from the distal end 108 of blade 142into an ETT compartment 148. In the depicted embodiment, a rear portionof guide stylet 146 is disposed inside the ETT at ETT compartment 148. Afront portion of guide stylet 146 is substantially positioned at acenter portion of blade 142. In some embodiments, guide stylet 146 issuspended along a portion blade 142. The suspension means that there isa space or a gap 111 between the guide stylet and blade such that theETT can be inserted into the blade and slipped over the guide stylet orthere is no physical connection between the guide stylet and the blade.Although the guide style is suspended, the guide stylet can makephysical contact with the blade for moving along the blade by a user orby a drive mechanism or move along a length of the blade. Thepositioning of the guide stylet allows an ETT to be slipped over theguide stylet and move along the guide stylet. As ETT 52 is positionedsubstantially concentric with guide stylet 146 at an insertion directionor a longitudinal axis of ETT 52 and guide stylet 146, the moving pathof ETT 52 is aligned with guide stylet 146. In this way, ETT 52 can bemoved into the trachea following guide stylet 146. In other words, theintubation system can intubate as long as the trachea is “seen” oridentified.

In some embodiments, blade 142 may be disposable so that blade 142 mayremain in the patient's mouth as a bite blocker to prevent the patient'sbiting on the ETT during the medical procedure. Blade 142 may be made ofdisposable materials, such as plastic. Blade 142 and ETT 52 may beconfigured to be a disposable package for one intubation. For example,blade 142 and ETT 52 may include a locking mechanism, such as a clipfitting to couple blade 142 with ETT 52 together once the ETT 52 isinserted into the trachea. In this configuration, blade 42 may be firstconnected to insertion guide device 144 or an ETT compartment 148. Then,ETT 52 may be preloaded into ETT compartment 148 from the distal end 108of blade 142.

In some embodiments, an ETT may have multiple segments and each of thesegments is adapted for a single use for one intubation. The ETT withthe multiple segments may be preloaded separately or in one integraltube with a predetermined length of segments separable via anyappropriate mechanism (e.g., via cutting) in a folded form in ETTcompartment 148. During an intubation, one ETT segment is separated fromthe rest of the ETT segments and the remaining ETT segments can be keptin ETT compartment for the next use.

FIG. 10A also illustrates a target point P and a light path M generatedby a precision light guide 70, such as a laser pointer located on guidestylet 146. The light from the laser pointer is directed to the tracheaopening as represented by point P when the trachea is located. ETT 52can be inserted toward the trachea opening following the target point Pand the light path M. As such, ETT 52 can be inserted correctly into thetrachea even if blade 142 has a curved configuration, ETT has to beinserted from a poor angle, or ETT 52 has to be pushed from a place farbehind blade 42.

FIG. 10A shows an unlocked position of guide stylet 146 and ETT 52 andFIG. 10B shows a locked position of guide stylet 146 and ETT 52. In thedepicted embodiment, guide stylet 146 is locked by a guide styletlocking solenoid 114 after ETT 52 is preloaded into ETT compartment 148.As guide stylet locking solenoid 114 is energized, guide stylet 146 iscoupled with a drive mechanism 116 to enable the motorized movement ofthe guide stylet. Drive mechanism 116 includes a leadscrew 118 that isdriven by a motor 120 via a drive gear 122. In the depicted embodiment,leadscrew 118 may cause the third DOF movement of guide stylet 46, thatis, forward and backward movement of guide stylet 146. The third DOFcauses the guide stylet to withdraw from a current position forpreparing movement in a different direction and then causes the guidestylet to move forward. The drive mechanism including the leadscrew canmove the guide stylet in a predetermined distance with desiredprecision.

Any appropriate drive mechanism can be used to perform the third DOFmovement. Referring to FIG. 11, an example roller motor driven mechanism400 is illustrated. For example, roller motor driven mechanism 400 maybe used to cause the third DOF movement. Roller motor driven mechanism400 may include a drive gear 420 motorized by a motor 410. Drive gear420 engages with a driven gear 430 to cause a guide stylet 146 to moveforward and backward relative to an engagement point. In the depictedembodiment, roller motor driven mechanism 400 may further be adjusted toreceive an ETT 52 and cause ETT 52 to move forward and backward. Rollermotor driven mechanism 400 may allow the guide stylet or ETT to move ina longer distance compared to the drive mechanism including theleadscrew. As another example, a telescoping mechanism may be used toperform the third DOF movement.

Returning to FIGS. 10A and 10B, drive mechanism 116 may further includea second motor 123 to perform the first DOF movement. Second motor 123may cause the first DOF movement by deflecting or articulating the guidestylet in a predetermined direction, i.e., up and down relative to theinsertion direction. In one embodiment as described above with referenceto FIG. 6, the guide stylet includes a directional cable. Thearticulation of the guide stylet may be accomplished by deflecting thedirectional cable. Similarly, drive mechanism 116 may include a thirdmotor 125 to perform the second DOF movement and third motor 125 maycause the second DOF movement by deflecting the guide stylet in apredetermined direction, i.e., right and left relative to the insertiondirection. Alternatively, four motors may be used to articulate the tipportion of guide stylet to perform multiple DOFs movements using atechnique known in the art.

It should be appreciated that the third DOF movement may be translatedforward and backward movement of the guide stylet or may be rotatedforward and backward movement of the guide stylet. Likewise, the firstDOF movement may be translated up and down movement of the guide styletor may be rotated up and down movement of the guide stylet, and thesecond DOF movement may be translated right and left movement of theguide stylet or may be rotated right and left movement of the guidestylet or snake-like movement.

The multiple DOFs movements manipulate the guide stylet to move in thedesired directions. For example, the third DOF movement can causewithdrawal of the guide stylet in a predetermined distance once it isdetermined that the trachea is not identified. The controlled withdrawalfollowed by the forwarding movement in an adjusted direction allowsquick maneuver of the guide stylet. Further, the guide stylet canrestart the search for the trachea from a predetermined point followingthe withdrawal. In this way, it is not necessary to withdraw the guidestylet substantially away from a place adjacent to the trachea oresophagus and initiate an insertion attempt again. Further, thesemi-automatic or automatic intubation makes it possible to intubate apatient with one hand.

In some embodiments, ETT 52 may be moved by an ETT drive. As shown inFIG. 10A, ETT 52 is preloaded in an ETT shuttle 124. FIG. 10A shows thatETT 52 is unlocked as ETT locking solenoid 126 is de-energized. FIG. 10Bshows that ETT 52 is locked as ETT locking solenoid 126 is energized. Inthe locked position in FIG. 10B, ETT may be moved forward and backwardin ETT shuttle 124 as shown by arrows. In the depicted embodiment, ETT52 can be pushed into the trachea automatically by the ETT shuttle.Alternatively, ETT 52 may be inserted into the trachea manually.

ETT compartment 148 may be separated from a main compartment 128 ofinsertion guide device 144 by a seal 130 to form an isolatedcompartment. FIG. 12A illustrates one embodiment of seal 130 thatincludes an accordion structure 132. Accordion structure 132 allows theseal extend or extract along its length such that ETT compartment 148remains sealed during the movement of ETT shuttle 124.

FIG. 12B illustrates another embodiment of seal 130. A large elastomericband 134 is shown to enclose the components, such as a drive mechanism116 and electronic components 135.

FIG. 12C illustrates yet another embodiment of seal 130. Seal 130 isshown to include a plurality of sheets 136 which are connected to eachother and movable relative to each other along a direction of theshuttle movement. In this way, ETT compartment 148 is separated from themain compartment 128 despite the shuttle movement.

ETT compartment 148 may further include a detachable mechanism, such asa clip or a snap fitting to remove ETT compartment 148 from theintubation system. The detachable mechanism may separate ETT compartment148 from the drive mechanism and other components of the intubationsystem.

ETT compartment 148 may need to be sterilized to receive ETT 52 beforean intubation procedure. A sealed compartment prevents fluid used forsterilization to enter into the main compartment 128. As such,components in contact with ETT 52, such as guide stylet and ETTcompartment 148 can be sterilized without affecting the electronic andmechanical components of the intubation system. That is, ETT compartment148 is water sealed for sterilization. Further, the guide stylet and theETT compartment may be removed from the intubation system forsterilization independently and then be reinstalled into the intubationsystem.

In some embodiments, an ETT compartment may not be included in theintubation system. The guide stylet may be loaded with an ETT or with aplurality of ETT segments, each segment for one intubation. A portion ofthe guide stylet in contact with other components of the insertion guidedevice is water sealed from the electronic components and drivecomponents for sterilization.

FIG. 13 is a schematic diagram of an intubation system 100 according toone embodiment of the present disclosure, illustrating examplecomponents of the intubation system. As illustrated in FIG. 13,insertion guide device 144 may include a user interface 140 and acontroller 150. User interface 140 may include a user input device 152to activate and operate intubation system 40. Further, user interface140 may include a display device 154 to present information, such as thenavigation element for the operation of the intubation system.

Controller 150 may be a microcomputer including a microprocessor unit ordata processor 156, an electronic storage medium or a memory 158, and acommunication interface 160. Data processor 156 and communicationinterface 160 may be linked by a bus to memory 158. Controller 150 mayalso be configured to communicate with a trachea identifying device 164via communication interface 160. Trachea identifying device 164 may beone of a gas exchange detector, an image capture device, a sounddetector, and a light detector. In some embodiments, memory 158 mayinclude both non-volatile and volatile memory, and programs oralgorithms may be stored in non-volatile memory and executed by theprocessor using portions of volatile memory to accomplish data analysisand the operations described herein. Storage medium read-only memory maybe programmed with computer readable data representing instructionsexecutable by the microprocessor for performing the data analysis andmethods described in the present disclosure as well as other variantsthat are anticipated but not specifically listed. For example, thecontroller may receive communication (e.g., input data) from the varioussensors, process the input data, and trigger the actuators in responseto the processed input data based on instruction or code programmedtherein corresponding to one or more routines.

In some embodiments, the intubation may be performed manually. Asdescribed above, trachea identifying device 164 may be disposed on guidestylet 146. When intubation system 100 is activated, a user may insertguide stylet 146 into the patient's mouth or nostril and then adjust aposition of guide stylet 146 based on the displayed navigation guidance.Additionally, or alternatively, the user may insert guide stylet 146 athis/her discretion.

In some embodiments, guide stylet 146 may be configured to movesemi-automatically or automatically. Intubation system 100 may furthercomprise a drive mechanism 116 operatively coupled to guide stylet 146and controller 150. Controller 150 may be configured to communicate withtrachea identifying device 164 and drive mechanism 116 via communicationinterface 160 to perform various operations described herein.

Drive mechanism 116 may be configured to cause desired movements ofguide stylet 146 and/or manually, semi-automatically, and/orautomatically, and may include one or more motors, drives, etc. In oneexample, desired movements may include, but are not limited to the firstDOF movement (e.g., forward and backward), the second DOF movement(e.g., up and down), the third DOF (e.g., right and left), or themovements in any direction or any angle relative to a guide styletposition. The guide's motion may include, but is not limited to linearmotion, 360° rotation, or combinations thereof. In some embodiments, atip portion of guide stylet 146 may be configured to perform steeringmotions, such as moving in any direction and guide stylet is configuredto follow the tip portion

In some embodiments, the guide stylet's movements may be fullyautomated. For example, controller 150 may be configured to include aprogram or an algorithm to move guide stylet 146 based on informationfrom trachea identifying device 164. As described above, the informationmay include a level of temperature, CO₂, O₂, sound, light, a gasexchange pattern, or a topographical pattern. In some embodiments, whenguide stylet 146 is inserted into a patient's mouth or nose andintubation system 144 is activated, the tip portion of guide stylet 146may be automatically moved forward and its position may be automaticallyadjusted in any desired directions relative to the position of guidestylet 146 to search for the trachea. It should be appreciated thatguide stylet 146 may be configured to perform any suitable movements tosearch for the trachea and move into the trachea. Further, it should benoted that any suitable known method known in the art may be used toenable the automated movements.

In some embodiments, the guide stylet's movements may be performedsemi-automatically. For example, the movements may be actuated throughuser input device 152. User-directed movements such as forward,backward, up, down, right or left movements in any direction relative tothe tip portion of guide stylet 146 may be actuated by a user usingcorresponding actuators on user input device 152.

Additionally, the use-directed movements and/or automated movements maybe guided by information, such as the navigation element presented ondisplay device 154. Alternatively, the movement may be activated orcontrolled by a user using a computing device via a network connection.

The easy trachea identification and the motorized movement of the guidestylet of the intubation system simplify the intubation and increase thesuccess rate of the intubation.

Additionally, or alternatively, intubation system 100 may be configuredto permit the user interaction during the automated or semi-automatedintubation process. For example, the automated guide movement may beoverridden by a user's input at any time. In this way, the intubationmay be further refined by the user.

FIG. 14 is a flowchart illustrating an example method 300 to intubate apatient using an intubation system according to one embodiment of thepresent disclosure. At 302, the method includes inserting a guide styletinto an upper airway of a patient. If the intubation is performed via apatient's nose, the guide stylet is inserted into a patient's nostril.If the intubation is performed via a patient's mouth, the blade may beinserted into the mouth and the blade may stop at a location adjacent atrachea opening or an esophagus opening when the blade is inserted intothe patient's mouth. In some embodiments, before 302, the methodincludes preloading an ETT into the guide stylet or preloading the ETTinto an ETT compartment of the intubation system for a pre-intubationstep.

Next, at 304, the method includes activating the intubation system andmoving the guide stylet. As described above, a moveable guide stylet maybe positioned inside the blade with a trachea identifying devicedisposed on a tip portion of the guide stylet. In some embodiments, theguide stylet may be positioned at a center portion of the blade andsuspended along the length of the blade. Alternatively, the guide styletmay be moved by a drive mechanism at the user's control via an actuatoror by a controller automatically.

In some embodiments, the trachea identifying device may detect airwaydata. For examples, the airway data may include image data or gasexchange data and the trachea identifying device may be an image capturedevice to detect image data or a gas exchange detector to detect gasexchange data. At 306, the method includes detecting gas exchange databy the gas exchange detector and/or capturing image data by the imagecapture device as the guide stylet moves in the airway.

At 308, the method analyzes or displays a gas exchange pattern of thedetected gas exchange data and/or a topographical pattern of thedetected image data. Any appropriate data analysis techniques can beused to determine the presence of a pattern indicating the tracheaopening. As described above, the pattern matching or pattern recognitionmay be used. Alternatively, the detected gas exchange data may bepresented in a graphical pattern that can easily identify the trachea,such as the patterns illustrated in FIGS. 6A and 6B. In another example,the captured image, such as a thermal image may be displayed directly asshown in FIGS. 5A and 5B.

Next, at 310, the method generates a navigation element based on thedetected data or data analysis. The navigation element may include anindication, such as “trachea found” or “trachea not found.”Alternatively, the navigation guidance may be a pattern indicating thetrachea opening or the trachea.

At 312, it is determined whether the navigation element indicates thatthe guide stylet is the trachea opening. If the answer is no, the methodgoes to 314 to adjust the guide stylet's movement. In one example, theadjustment may include withdrawing the guide stylet partially and thenchanging the moving direction. In another example, the guide stylet maybe adjusted from the third DOF movement (e.g., forward and backward) tothe first DOF movement (e.g., up and down) to the second DOF movement(e.g., right and left). From 314, the method goes to 306 to repeat thesteps of the data detection and analysis.

If the answer at 312 is yes, the method continues to 316 to confirm thatthe guide stylet is in the trachea. In some embodiments, the trachealocation may be confirmed by repeated indication from the navigationelement based on the same type of detected airway data. In otherembodiments, the navigation element generated from different type of thedetected airway data may be used confirm the determination. For example,the navigation element based on a topographical pattern may indicatethat the guide stylet is in front of the trachea opening. After thedetermination that the guide style is in the trachea opening, a secondnavigation element based on a gas exchange pattern, such as a CO₂pattern may be used to confirm that the guide stylet is in the trachea.

Next, at 318, the ETT is slipped over the guide stylet and is placed inthe trachea at an appropriate position. Steps 304 and 318 constitute anintubation stage.

Next, at 320, the method includes inflating an ETT balloon andwithdrawing the guide stylet with or without the blade. In someembodiments, the blade is disposable and remains in the mouth as a biteblocker. If the blade remains in the mouth, the method includes clippingand locking the ETT with blade. The steps 318 and 320 constitute apost-intubation stage.

The method described above enables an automatic or semi-automaticmovement of the guide in response to the navigation guidance generatedfrom real time data. Thus, the position of the guide stylet can becontinually adjusted through feedback from the navigation guidance. Inthis way, the guide stylet can be accurately and quickly inserted intothe trachea.

It should be appreciated that the method can be used in an intubationsystem including a CO₂ sensor, an O₂ sensor, an airflow sensor, apressure sensor, a temperature sensor, a light sensor or a sounddetector. The navigation element can be generated based on informationfrom one of a CO₂ sensor, an O₂ sensor, a temperature sensor, a lightsensor or a sound detector.

FIG. 15 shows an example intubation device 400 according to anotherembodiment of the present disclosure. Intubation device 400 may beconfigured to enable an ETT 52 to be arranged in-line with a guidestylet 446, referred to as an in-line alignment or an in-linearrangement herein. That is, ETT 52 can move in a path the same as amoving path of guide stylet 446. Intubation device 400 includes aninsertion guide device 402 and a blade body 404. Insertion guide device404 may include electronic components for identification of a tracheaopening or a trachea.

Blade body 404 may include a blade 442. Blade 442 may be any shapesuitable to insert into an upper airway of a patient and facilitatemoving a patient's tongue forward and upward. Further, Blade 442 may besized to receive ETT 52. In the depicted embodiment, blade 442 has aconcave surface to form a hollow space under the surface and the bladeis curved toward a distal end 410. In one example, blade 442 may have alength L such that distal end 410 is positioned adjacent to a patient'strachea opening when blade 442 is inserted into a patient's mouth. Awidth of the blade may be sized to facilitate a movement of ETT 52 alongthe blade. Alternatively, blade 442 may be any appropriate shape forintubation, such as a conventional laryngoscope blade. In oneembodiment, blade body 404 is releasably connected to insertion guidedevice 402.

Intubation device 400 may include guide stylet 446. In some embodiments,guide stylet 446 may fixed at a mounting portion 412 at insertion guidedevice 402. Alternatively, guide stylet 446 may fixed at blade body 402.Guide stylet 446 is suspended along a length of blade 442 adjacent orunder the concave surface of the blade. In some embodiments, guidestylet 446 may be positioned substantially centrally along the length ofblade 442 and may be suspended along an entire length of the blade andextended over a proximal end 414 of the blade. In some embodiments,guide stylet 446 may include a tip 416 adjacent to distal end 410 of theblade, a first section 418 disposed along the length L of the blade anda second section 420 extending between mounting portion 412 and proximalend 414 of the blade. Guide stylet 446 may be made of rigid materials,such as metal or hard plastic to have stiffness required to be suspendedsubstantially stationary. In some embodiments, the guide stylet can besuspended rigidly with the support at one point or is suspendedsubstantially at a fixed position via the support at one location. Guidestylet 446 is coupled with other components of intubation devicemechanically, electronically or optically.

In the depicted embodiment, the guide stylet is substantially stationaryor has zero degree of freedom movement. In some embodiments, firstsection 420 of the guide stylet is configured to have a sufficientlength between mounting portion 412 and proximal end 414 of the bladesuch that a total length of the guide style is greater than a length ofthe ETT 52 to allow preloading or loading of ETT 52 along the guidestylet. ETT 52 may be preloaded to ETT loading section 420 from distalend 410 of the blade. In some embodiments, guide stylet 442 may bereleasably connected to the insertion guide device and may be detachablefor sterilization or replacement.

As shown in FIG. 15, ETT 52 can be moved over guide stylet 446 towarddistal end 410 of the blade. As such, ETT 52 can be pushed into theairway along the guide stylet.

In some embodiments, blade 442 may be disposable and made of materials,such as plastic. Further, blade 442 may be remained in the patient'smouth as a bite blocker. Blade 442 and ETT 52 may be locked together bya locking mechanism once the intubation is completed. For example, asshown in FIG. 9, blade 442 may include a clip 424 and ETT 52 may includea complementary clip 426 to couple blade 442 and ETT 52 together. Anyappropriate locking mechanism may be used to lock the blade with theETT.

In some embodiments, a trachea identifying device, such as a lightsource or a video camera may be disposed on a tip 416 of guide stylet446. The trachea identifying device is coupled to the insertion guidedevice electronically and/or optically. A trachea opening may beidentified through a direct view of the trachea opening via illuminationprovided by the light source or identified through an indirect view ofthe trachea opening via an image captured by the video camera. In otherwords, the trachea opening may be identified by a view of an airwaypattern or a topographical pattern. As the ETT is aligned in-line withthe guide stylet, the ETT is in a line of view the same as that of theguide stylet. In other words, it can be intubated as long as the tracheaopening can be identified.

The precision of an ETT insertion into the trachea opening may furtherbe improved by using a precision light guide (not shown). In someembodiments, tip 416 of the guide stylet may include a precision lightguide, such as a laser pointer or other light pointers located on guidestylet 146. The light ray from the laser pointer is directed to thetrachea opening once the trachea opening is identified by the tracheaidentifying device in tip 416 of the guide stylet. ETT 52 can be pushedtoward the trachea opening following the light ray. As such, ETT 52 canbe inserted correctly into the trachea.

It should be appreciated that any appropriate trachea identifying devicecan be used. For example, the trachea identifying device may be anairway sensor, such as a light source, an image capture device, a gasexchange detector, a sound detector or a light detector as describedabove. In one example, the airway sensor may generate an airway patternviewable to a user and the trachea opening may be identified by airwayfeatures indicated or displayed on the airway pattern. For example, insome embodiments, the airway sensor may be an image capture device, suchas a video camera or a thermal camera to capture and display the imagesof the airway pattern including the image of the trachea opening, theesophagus opening and their surroundings. The trachea opening may beidentified based on airway features or topographical features of thetrachea opening. The topographical features may include an inverted Vshape of vocal cords, white color of the vocal cords, vocal cord foldsvibration, and vocal cord's spatial relationship to its surroundingstructures, such as epiglottis, a glottis, and arytenoids. In someembodiments, the airway sensor may be a gas exchange detector togenerate an airway pattern or a gas exchange pattern in a respiratorycycle. The gas exchange pattern may be displayed to a user of theintubation device. The trachea opening is identified based on the gasexchange features of the gas exchange pattern.

Further, it should be appreciated that the intubation device may includea data processor configured to analyze the airway data to determine anairway pattern indicating a trachea opening based on airway features. Insome embodiments, the airway data may be analyzed via pattern matchingby comparing the airway features of the image data with a predeterminedpattern as described above. In some embodiments, the airway data may beanalyzed via pattern recognition as described above. Further, asdescribed above, a navigation element may be generated to direct amovement of the guide stylet to the trachea opening.

FIG. 16 shows an example intubation device 500 according to anotherembodiment of the present disclosure. Intubation device 500 includes aninsertion guide device 502 and a blade assembly 504. Insertion guidedevice 504 may include electronic components for identification of atrachea opening or a trachea. Blade assembly 504 includes a blade 542and a guide stylet 546. Similar to the embodiment illustrated in FIG.15, blade assembly 502 is configured to have an in-line alignment of theguide stylet 546 and an ETT 52. In the depicted embodiment, blade 542includes a press plate 510 and a side plate 512. Press plate 510 has asurface curved along a length of the blade and the length is sized toallow a distal end 514 of the blade to be positioned adjacent to thetrachea opening once the blade is inserted into a patient's mouth. Pressplate 510 may depress a patient's tongue to allow a view of the tracheaopening or the vocal cords. Side plate 512 extends from a surface ofpress plate 510 and is substantially perpendicular to press plate 510.Side plate 512 may constrain ETT 52 to move along the surface of pressplate 510. Again, blade 542 may have any appropriate shape.

Guide stylet 546 may include a first section 516 to be disposed along alength of blade 542 and a second section 518. Second section 518 may bein a folded configuration, where one or more segments are folded on atop or below substantially one or more other segments. For example, insome embodiments, the folded configuration may include a staggerconfiguration, an L-shaped configuration, an S-shaped configuration, aspiral configuration, a helical configuration. In some embodiments, theguide stylet may be made of rigid materials, such as metal or hardplastics so that the guide stylet may be rigidly suspended over blade542 or suspended substantially stationary while the guide stylet isfixed at one mounting portion 520 or one point at a connection block 522of the blade assembly. In some embodiments, guide stylet 546 may beconnected to connection block 522 by any appropriate connectionmechanism, such as welding at mounting portion 520. Blade assembly 504may be releasably connected to insertion guide device 502. Guide stylet546 is coupled with insertion guide device 502 mechanically,electronically or optically.

As guide stylet 546 is suspected all the way from a distal end 514 tomounting portion 518, ETT 52 can be loaded from distal end 514 of theblade to second section 518 of the guide stylet. That is, the ETT 52 canbe moved over the guide stylet. Further, a precision light guide may bedisposed on a tip of guide stylet to direct the ETT's movement.

As described above with reference to FIG. 15, a trachea identifyingdevice may be disposed on a tip 524 of guide stylet 546 to identify thetrachea opening. It should be appreciated that any appropriate tracheaidentifying device can be used. For example, the trachea identifyingdevice may be an airway sensor, such as a light source, an image capturedevice, a gas exchange detector, a sound detector or a light detector asdescribed above. The trachea opening can be identified based oninformation from the image capture device or the gas exchange detector.In one example, an airway pattern may be used to identify the tracheaopening as described above. Further, it should be appreciated that theguide stylet may be flexible.

Intubation device 500 has advantage of in-line arrangement of the guidestylet and the ETT. Further, as one section of the guide stylet isfolded and the ETT can be loaded along the folded segments of the guidestylet, the blade assembly is compact.

FIG. 17 shows a cross-sectional view of a blade assembly 600 accordingto another embodiment of the present disclosure. Blade assembly 600 mayhave an in-line alignment as described above with reference to FIGS. 15and 16. Blade 642 may be formed of a tube configuration. Outsidesurfaces 610 of blade 642 is of a rectangular shape with round corners612 and inside surfaces 614 of blade 642 is circular to accommodate aninsertion of the ETT. Blade 642 may be curved along its length tofacilitate positioning into a patient's mouth.

Guide stylet 646 is shown to be substantially in middle portion of blade642. Guide stylet may be sized to receive a trachea identifying device.Guide stylet 642 may be rigid and fixed to a blade assembly or anintubation device as described above with reference to FIGS. 15 and 16.While guide stylet is shown to have a circular configuration, it can beany appropriate shape.

In the depicted embodiment, a side wall 616 of blade 646 includes apassage 618 to accommodate an ETT balloon and accessories forafter-intubation use. Side wall 616 may also include one or more slots(not shown) so that a user can observe a movement of ETT as ETT ispushed into the trachea.

According to one aspect of the present disclosure, a blade assembly ofan intubation system comprises a blade having a distal end wherein thedistal end is adjacent to a trachea opening when the blade is insertedinto an upper airway of a patient; and a guide stylet suspended along aportion of the blade and extended along the blade. An ETT can be loadedfrom a distal end of the blade into the guide stylet. In one embodiment,the guide stylet is rigidly fixed to the intubation system andunmovable.

In another embodiment, the guide stylet is moveable by a drive mechanismto perform one ore multiple degrees freedom movements. The blade can befunctioned as a guide rail to facilitate movement forward and backwardof the guide stylet along an insertion direction and the distal end ofthe blade is a fulcrum for the movement of the guide stylet in at leastone degrees of freedom. In still another embodiment, the intubationsystem further comprises a guide stylet locking solenoid to couple theguide stylet with the drive mechanism and an endotracheal tube lockingsolenoid to couple the endotracheal tube with an endotracheal tubeshuttle to enable movement of the endotracheal tube by the endotrachealtube shuttle.

Note that various steps or functions illustrated may be performed in thesequence illustrated, in parallel, or in some cases omitted. Likewise,the order of processing is not necessarily required to achieve thefeatures and advantages of the example embodiments described herein, butis provided for ease of illustration and description. One or more of theillustrated steps or functions may be repeatedly performed depending onthe particular strategy being used. Further, the described steps maygraphically represent code to be programmed into the computer readablestorage medium in guide control device.

Note that various steps or functions illustrated may be performed in thesequence illustrated, in parallel, or in some cases omitted. Likewise,the order of processing is not necessarily required to achieve thefeatures and advantages of the example embodiments described herein, butis provided for ease of illustration and description. One or more of theillustrated steps or functions may be repeatedly performed depending onthe particular strategy being used. Further, the described steps maygraphically represent code to be programmed into the computer readablestorage medium in guide control device.

1. A method for intubating a patient, comprising: inserting a guidestylet of an intubation system into an upper airway of the patient;collecting airway data; analyzing the airway data using patternrecognition; and generating a navigation element based on the patternrecognition to direct a movement of the guide stylet to a tracheaopening.
 2. The method of claim 1, wherein performing the patternrecognition includes extracting features from the collected airway dataand classing the collected airway data based on the extracted features.3. The method of claim 1, wherein the pattern recognition is performedvia unsupervised learning.
 4. The method of claim 3, wherein theunsupervised learning includes establishing classes for the collectedairway data based on statistical regularities of the collected airwaydata.
 5. The method of claim 1, wherein the pattern recognition isperformed via supervised learning.
 6. The method of claim 5, wherein thesupervised learning includes classing the airway data based on a priorknowledge.
 7. The method of claim 6, wherein the prior knowledge is aset of classified patterns.
 8. A method for intubating a patient with anintubation system, comprising: inserting a guide stylet of theintubation system into an upper airway of the patient; activating theintubation system and moving the guide stylet; capturing airway datawith a trachea identifying device positioned on the guide stylet; andanalyzing the airway data with a data processor of the intubationsystem, the data processor using pattern recognition to analyze theairway data, and the data processor performing the pattern recognitionvia unsupervised learning.
 9. The method of claim 8, wherein theunsupervised learning includes establishing classes for classing theairway data based on statistical regularities of patterns of the airwaydata.
 10. The method of claim 8, wherein the pattern recognition isfurther performed via supervised learning.
 11. The method of claim 8,wherein the data processor generates a navigation element based on thepattern recognition to direct a movement of the guide stylet to atrachea opening.
 12. The method of claim 11, wherein the airway dataincludes topographic features of the upper airway, and wherein the dataprocessor performs the pattern recognition based on a statistical modelof the topographic features via the unsupervised learning.
 13. Themethod of claim 12, wherein the topographic features are one or more oftopographic features of the trachea, an esophagus, and surroundings ofthe trachea and the esophagus.
 14. The method of claim 8, furthercomprising, indicating a position of the guide stylet relative to atrachea opening based on the airway data.
 15. A method for intubating apatient using an intubation system, comprising: inserting a guide styletof the intubation system into an upper airway of the patient; activatingthe intubation system and moving the guide stylet; detecting airway datawith a trachea identifying device as the guide stylet is moved in theupper airway; analyzing the airway data with a data processor of theintubation system, the data processor using pattern recognition toanalyze the airway data, and the data processor performing the patternrecognition via supervised learning; indicating a position of the guidestylet relative to a trachea opening based on the airway data; andgenerating a navigation element to direct a movement of the guide styletto the trachea opening based on the pattern recognition.
 16. The methodof claim 15, wherein the data processor further performs the patternrecognition via unsupervised learning.
 17. The method of claim 15,wherein the airway data includes topographic features of the upperairway including one or more of topographic features of the trachea, anesophagus, and surroundings of the trachea and the esophagus.
 18. Themethod of claim 17, wherein the data processor stores one or more setsof classified patterns to perform the pattern recognition on thetopographic features of the upper airway via the supervised learning.19. The method of claim 15, wherein the trachea identifying device is anairway sensor.
 20. The method of claim 19, wherein the patternrecognition is pattern recognition of a gas exchange pattern.